Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 4 of 4 for:    21775347 [PUBMED-IDS]

A Study of Patients Undergoing Total Knee and Hip Arthroplasty at a Regional Hospital in Denmark

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03008967
Recruitment Status : Completed
First Posted : January 4, 2017
Last Update Posted : February 2, 2018
Sponsor:
Information provided by (Responsible Party):
Troels Mark Christensen, Bornholms Regionskommune

Brief Summary:
This project will be a descriptive, hypothesis-generating study. The aim is to identify risk factors for poor response to rehabilitation programs after TJR and use these to identify patients who are most susceptible to poor outcomes in order to optimise appropriate rehabilitations strategies and rationalising the distribution of health care resources.

Condition or disease Intervention/treatment
Arthroplasty, Replacement, Knee Arthroplasty, Replacement, Hip Other: Arthroplasty and postoperative rehabilitation.

  Show Detailed Description

Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 110 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Months
Official Title: A Prospective Cohort Study of Patients Undergoing Total Knee and Hip Arthroplasty at a Regional Hospital in Denmark
Study Start Date : September 2016
Actual Primary Completion Date : February 2018
Actual Study Completion Date : February 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Total Knee and Hip Arthroplasty
Rehabilitation, observational. Identification of risk factors for poor response to rehabilitation programs after TJR and use these to identify patients who are most susceptible to poor outcomes
Other: Arthroplasty and postoperative rehabilitation.
Patients undergoing total knee or total hip arthroplasty and their response to postoperative rehabilitation.




Primary Outcome Measures :
  1. 30 second chair stand test, to test the patients functional capacity [ Time Frame: Change of 30 second chair stand test from baseline to follow up (an average of 3 months) ]

Secondary Outcome Measures :
  1. Health-related quality of life questionnaire [ Time Frame: Change of health-related quality of life questionnaire from baseline to follow up (an average of 3 months) ]
    Knee injury and Osteoarthritis Outcome Score (KOOS) or Hip disability and Osteoarthritis Outcome Score (HOOS)

  2. Pain catastrophizing scale questionnaire [ Time Frame: Change of pain catastrophizing scale questionnaire from baseline to follow up (an average of 3 months) ]
  3. Use of analgesics and other medication, qualitative assessment [ Time Frame: Changes in the use og analgesics and other medication from baseline to follow up (an average of 3 months) ]
  4. Fall history, events as numbers of falls described by the patient [ Time Frame: Change within the fall history from baseline to follow up (an average of 3 months) ]
  5. Patient expectations questionnaire [ Time Frame: Preoperative (an average 3 weeks before surgery) ]
  6. Patient satisfaction questionnaire [ Time Frame: At follow up (an average of 3 months postoperative). ]
  7. The Forgotten Joint Score questionnaire [ Time Frame: At follow up (an average of 3 months postoperative). ]
  8. Rehabilitation compliance [ Time Frame: At the culmination of the rehabilitation program, an average of 10 weeks. ]
    Physiotherapist subjective assessment of patient compliance to the rehabilitation program



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients who are scheduled to undergo a total joint replacement (total knee arthroplasty or total hip arthroplasty) at Bornholms regional hospital will be invited to participate.
Criteria

Inclusion Criteria:

  • patients undergoing total knee arthroplasty or total hip arthroplasty
  • must be able to participate in postoperative rehabilitation
  • must be able to talk and understand Danish or English

Exclusion Criteria:

  • None

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03008967


Locations
Layout table for location information
Denmark
Genoptræningen
Rønne, Bornholm, Denmark, 3730
Sponsors and Collaborators
Bornholms Regionskommune
Investigators
Layout table for investigator information
Principal Investigator: Troels M. Christensen, MSc Bornholms Regionskommune

Additional Information:

Publications:
Thomsen, M. G. (2015). Comparison of Vanguard XP and Vanguard CR Total Knee Arthroplasties. A Trial Evaluating Early Component Migration by RSA and Patient Reported Outcome. Study is ongoing.

Layout table for additonal information
Responsible Party: Troels Mark Christensen, Physiotherapist, B.Pt., M.Sc., Bornholms Regionskommune
ClinicalTrials.gov Identifier: NCT03008967     History of Changes
Other Study ID Numbers: 2016-41-4783
First Posted: January 4, 2017    Key Record Dates
Last Update Posted: February 2, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Keywords provided by Troels Mark Christensen, Bornholms Regionskommune:
Total Knee Arthroplasty
Total Hip Arthroplasty
Rehabilitation